a study of ly2216684 in participants with major depression disorder

Conditions: Major Depressive Disorder

Summary: the primary objective of this study is to evaluate the long-term safety and tolerability of ly2216684 administered once daily in the adjunctive treatment with an selective serotonin reuptake inhibitors (ssri) for up to approximately 1 year in participants with major depressive disorder (mdd) who were partial responders to their ssri treatment.


Eligibility criteria:
inclusion criteria: * participants must have completed study lnbm: nct01173601 or study lnbq: nct01187407 * participants must be competent and able to give their own informed consent exclusion criteria: * participants that have had or currently have any additional ongoing diagnostic and statistical manual of mental disorder, fourth edition, text revision (dsm-iv-tr) axis i condition other than major depression that was considered the primary diagnosis within 1 year of entering trial * participants that have had any anxiety disorder that was considered a primary diagnosis within the past year * participants that have a current or previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder * participants that have a history of substance abuse within the past 1 year, and/or substance dependence within the past 1 year, not including caffeine and nicotine * participants that have an axis ii disorder that, in the judgment of the investigator, would interfere with compliance with the study * participants that have had a lack of full response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks, or in the judgment of the investigator, the participant has treatment-resistant depression * participants that have a history of electroconvulsive therapy (ect), transcranial magnetic stimulation (tms), or psychosurgery within the last year * participants who are women who are pregnant or breastfeeding * participants who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others * participants that have a serious or unstable medical illness * participants that have any diagnosed medical condition which could be exacerbated by noradrenergic agents * participants that have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions * participants that have a history of any seizure disorder (other than febrile seizures) * participants that have received treatment with a monoamine oxidase inhibitor (maoi) within 14 days prior to entering trial or have a potential need to use an maoi within 3 days after discontinuation from the study * participants that require psychotropic medication other than sedative/hypnotic medication for sleep * participants who are taking or have received treatment with any excluded medications within 7 days prior to entering trial * participants that have a thyroid stimulating hormone (tsh) level outside the laboratory established reference range. participants previously diagnosed with hyperthyroidism or hypothyroidism who have been treated with a stable dose of thyroid supplement for at least the past 3 months, and who are clinically and chemically euthyroid will be allowed to participate in the study. * participants that have initiated or discontinued hormone therapy within the previous 3 months prior to enrollment * participants that have initiated psychotherapy, change in intensity of psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or at any time during the study. * participants have a positive urine drug screen (uds) for any substances of abuse on entering trial * participants have significantly violated rules that a participant must comply with during study lnbm: nct01173601 or study lnbq: nct01187407